Vicks Medinait Syrup 90 ml

WARNINGS
Before use ask the patient if he has a cough that occurs with excessive phlegm (mucus) or a persistent cough, such as that which occurs with smoking, asthma, or emphysema. High or prolonged doses of paracetamol, present in the product, can cause high-risk liver disease and even serious changes in the kidney and blood. Paracetamol should be used with caution in subjects with renal or hepatic insufficiency, including those with non-alcoholic cirrhotic liver disease. The dangers of overdose are greater in those with alcoholic liver disease. Do not use with any other product containing paracetamol. The use of the product is not recommended if the patient is being treated with anti-inflammatories. During therapy with oral anticoagulants the doses should be reduced. In the rare cases of occurrence of allergic reactions, administration should be suspended. Particular caution is needed in determining the dose in elderly subjects, in consideration of their greater sensitivity 'towards antihistamines. The use of antihistamines at the same time as certain ototoxic antibiotics can mask the first signs of ototoxicity, which can only reveal itself when the damage is irreversible. The product should be administered with caution in patients with cardiovascular disease, hypertension, hyperthyroidism. Caution should be exercised in patients with a history of hypertension and / or heart failure as fluid retention and edema have been reported in association with NSAID therapy. Additive effects may occur with alcohol, hypnotics, sedatives or tranquilizers which therefore should not be taken at the same time. The use of the medicinal product should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which can be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin. When gastrointestinal bleeding or ulceration occurs in patients taking the medicinal product, discontinue treatment. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases in the early stages of treatment. The drug should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. The product contains sucrose, which must be taken into account in case of low calorie diets. After 3 days of continuous use, without noticeable results, consult your doctor. Use the measuring cup included in the package. The product should be taken only before going to bed for a night's rest and on a full stomach. Do not exceed the recommended doses: in particular elderly patients should strictly follow the minimum dosages indicated above.
PHARMACOTHERAPEUTIC CATEGORY
Antitussives, excluding associations with expectorants.
STORAGE
None. Any variation in the color of the syrup will not affect the quality of the product.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'individual ascertained to the components; children under 12 years of age; asthma, diabetes, glaucoma, prostatic hypertrophy, stenosis of the gastrointestinal and urogenital tract, epilepsy, severe liver disease or severe renal impairment; paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and in those affected by severe haemolytic anemia; history of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding); severe heart failure; in case of concomitant administration with MAOIs (monoamine oxidase inhibitors) or within two weeks of taking MAOIs.
NAME
VICKS MEDINAIT
EXCIPIENTS
Propylene glycol, sodium citrate dihydrate, citric acid monohydrate, sodium benzoate, polyethylene glycol 300, sugar (sucrose), glycerin, anethole, quinoline yellow (E 104), brilliant blue FCF (E133), mineralized water.
SIDE EFFECTS
In general, no serious side effects are expected. Blood and lymphatic system disorders: Blood dyscrasias, such as thrombocytopenia, agranulocytosis, haemolytic anemia, neutropenia, leukopenia, pancytopenia, have been reported very rarely with the use of paracetamol or doxylamine, but these were not necessarily causally related. cases of allergy or hypersensitivity reactions' with paracetamol and doxylamine, including rash, urticaria, anaphylaxis and bronchospasm are rare. Hypersensitivity reactions have also been reported, such as angioedema, larynx edema, anaphylactic shock. Nervous system disorders: Somnolence is common with doxylamine and may occur rarely with dextromethorphan. Other side effects that are more common with antihistamines such as doxylamine are headache, blurred vision and psychomotor impairment. Dextromethorphan is also rarely associated with dizziness. Gastrointestinal disorders: the most commonly observed adverse events are gastrointestinal in nature. Dry mouth, constipation and increased gastric reflux can occur with antihistamines, such as doxylamine. Gastrointestinal disorders which may rarely occur with doxylamine or dextromethorphan, include nausea, vomiting, abdominal pain, diarrhea. Flatulence, dyspepsia, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported. Gastritis has been observed less frequently. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly. Hepatobiliary disorders: impaired liver function and hepatitis. In case of overdose, paracetamol can cause hepatic cytolysis, which can evolve towards massive and irreversible necrosis. Skin and subcutaneous tissue disorders: rarely with the use of paracetamol hypersensitivity including skin rashes and urticaria may occur. Skin reactions of various types and severity have been reported with the use of paracetamol including cases of erythema multiforme and bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (very rarely). With the use of pseudoephedrine and also dextromethorphan, rashes have been rarely reported, with or without irritation. Renal and urinary disorders: antihistamines, such as doxylamine, can cause urinary retention or difficulty in urination, alterations in the kidney (acute renal failure, interstitial nephritis, hematuria, anuria). Other adverse effects: antihistamines can also cause asthenia, photosensitivity and, at high doses, convulsions, breathing difficulties due to thickening of bronchial secretions, and, especially in the elderly, extrasystoles, tachycardia and hypotension. Edema, hypertension and heart failure have been reported in association with NSAID treatment. The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product.
PREGNANCY AND BREASTFEEDING
Do not use during pregnancy nor during lactation. Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and antiplatelet effect that can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.
INDICATIONS
Treatment of cold and flu symptoms.
INTERACTIONS
Do not use during or in the two weeks following treatment with antidepressant drugs (anti-MAO). Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine and even alcohol). These substances can increase the hepatotoxicity of paracetamol. The administration of paracetamol can interfere with the determination of uric acid (by the method of phosphotungstic acid) and that of glycaemia (by the method of glucose-oxidase-peroxidase). The rate of absorption of paracetamol can be increased by metoclopramide or domperidone and absorption can be reduced by cholestyramine. There is a potential for interaction between dextromethorphan and medicinal products that inhibit the CYP2D6 isoenzyme such as SSRIs (e.g., fluoxetine, paroxetine). Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking the drug concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
DOSAGE
Adults and children over 12 years: one level measuring cup (30ml = 2 tablespoons), once a day, for no more than 3 days.
ACTIVE PRINCIPLES
Dextromethorphan hydrobromide 0.0500 g; doxylamine succinate 0.0250 g; paracetamol 2.0000 g.